The Debate is Over: Changing the Conversation Around Concussion DiagnosticsAugust 27, 2013 No Comments
The Cleveland Clinic today launched an expansion of their iPad-based concussion testing platform to rural communities in Iowa as highlighted by a recent mobihealthnews article. The Cleveland Clinic has been working on building this technology for the past 18 to 24 months and it is exciting to see that an institution such as the Cleveland Clinic is taking such an interest in mobile concussion diagnostics. Currently the Cleveland Clinic technology is working through the logistics of distribution and has not yet launched to the public for sale. The C3 Logix app is still being tested in Cleveland area schools and now in a rural area Iowa high school inventor Jay Alberts commented.
The C3 technology is interesting and brings up the debate over the need for Food and Drug Administration (FDA) clearance with mobile-based medial diagnostics. The concussion industry has traditionally shied away from the FDA and avoided terms like diagnostic or medical device even though in a traditional sense this is exactly what concussion assessment tools are. It will be interesting to see if the C3 has taken the route of being a medical device developed with an appropriate quality system and meeting the standards of the FDA. It appears that their delay in launch is likely an effort to continue beta testing and while deciding on whether to submit an application to the FDA.
This decision was the center of Sway Medical’s culture moving forward. As the Founder and CEO of the company, it was imperative that we transition the conversation of concussions as “dings, stingers, bell ringing” into categorizing them as a true medical condition necessitating review by the agencies that regulate medical devices and by qualified medical professionals.
The FDA guidelines on mobile devices state that:
“Apps that use a mobile platform to record response time and accuracy of patients completing a cognitive task and/or automatically score or interpret cognitive testing results”
“Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user’s movement to determine conditions such as sleep apnea, sleep phase, fall detection, or detect motion related to other conditions or diseases or to measure heart rate”
In order to drive acceptance of mobile as medical instead of as pseudo-medical or wellness, it is important to commit to the same standards and regulations that every other medical device is held to.
Modernizing the healthcare system through the advancement of analytics and technology can only be done with a commitment to quality standards and avoiding the lure of revenue before regulatory validation.
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